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Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

This study has been withdrawn prior to enrollment.
Information provided by:
Pfizer Identifier:
First received: January 26, 2011
Last updated: April 7, 2011
Last verified: April 2011
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.

Condition Intervention Phase
Healthy Drug: alprazolam commercial sublingual formulation Drug: alprazolam test sublingual tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC) [ Time Frame: 11 days ]
  • Alprazolam bioavailability as assessed by peak concentration (Cmax) [ Time Frame: 11 days ]

Secondary Outcome Measures:
  • Alprazolam time of maximum concentration (Tmax) [ Time Frame: 11 days ]
  • Half life of alprazolam [ Time Frame: 11 days ]
  • Clinically significant safety laboratory tests [ Time Frame: 11 days ]
  • Clinically significant adverse events [ Time Frame: 11 days ]
  • Clinically significant vital signs [ Time Frame: 11 days ]

Estimated Enrollment: 26
Study Start Date: April 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alprazolam commercial sublingual tablet Drug: alprazolam commercial sublingual formulation
0.5 mg tablet, single dose
Experimental: Alprazolam test sublingual tablet Drug: alprazolam test sublingual tablet
0.5 mg tablet, single dose


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy male or female subjects
  • BMI 18 to 26.9
  • must give informed consent

Exclusion Criteria:

  • clinically significant disease
  • narrow angle glaucoma
  • positive drug screen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01285505

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01285505     History of Changes
Other Study ID Numbers: A6131020
Study First Received: January 26, 2011
Last Updated: April 7, 2011

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017